NDAORALSOLUTION
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
3/8 — Basic
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIGAFYDE (vigabatrin) is an oral anti-epileptic solution approved by the FDA in June 2024 under NDA by Dr. Reddy's Laboratories. The drug is indicated for epilepsy management and represents a formulation innovation in the anti-epileptic agent class. Vigabatrin works as an anti-epileptic medication to reduce seizure activity in eligible patient populations.
Growth17.0 years to LOE
Early-stage product in growth phase with limited competitive pressure, indicating opportunity for team expansion in commercial and medical affairs roles.
Mechanism of Action
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
Started Jun 2012
0Infantile Spasms
Vigabatrin for the Treatment of Cocaine Dependency
Started Jan 2011
207 enrolled
Cocaine AddictionCocaine Dependence
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
Started Dec 2010
65 enrolled
Adult Refractory Complex Partial Seizures
Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
Started Jul 2008
55 enrolled
Methamphetamine Dependence
Vigabatrin for Treatment of Cocaine Dependence
Started Jan 2008
186 enrolled
Cocaine Dependence
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.